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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05297955
Other study ID # TJ-IRB20211242
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2013
Est. completion date March 15, 2022

Study information

Verified date March 2022
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators examined circulating tumor cells (CTC) in the perioperative peripheral blood of hundreds of HCC patients undergoing liver cancer surgery using CellSearch technology between 2013 and 2016. Although the investigators have done a preliminary study of the above data and published some results, the previous study was only a basic analysis. Now the investigators plan to carry out further in-depth analysis of these data, including hospitalization data, follow-up results, surgical tumors and blood specimens, and make full use of biostatistics, molecular biology, pathology and other related techniques to elucidate the association between the levels of CTC or CTC clusters and patients' disease during the perioperative period, and to explore the molecular basis of CTC production in hepatocellular carcinoma.


Description:

From 2013 to 2016, CellSearch technology was used to detect the number of circulating tumor cells (CTC) in peripheral blood of hundreds of HCC patients undergoing liver cancer surgery during perioperative period. The analysis results confirmed that the level of CTC before and after surgery were significantly correlated with overall survival (OS) and disease-free survival (DFS) of patients. CTC level changed before and after surgery, but there was no statistical difference. Preoperative CTC was more correlated with patients' disease-related clinical parameters, while postoperative CTC was an independent prognostic indicator of patients after surgery. In addition, the investigators' study found that CTC clusters level can be a new marker of tumor progression in HCC patients. Based on the above data, the investigators will perform retrospective analysis to compare the relationship between CTC level and clinical indicators of HCC patients. Participants were divided into groups according to pathological type, differentiation degree, clinical stage, invasion degree, recurrence and metastasis of tumors. Combined with immunohistochemistry and quantitative PCR results, the correlation of CTC in tumor genesis, pathological model, degree of differentiation, tumor stage, invasion, metastasis and expression of other tumor markers was studied.


Recruitment information / eligibility

Status Completed
Enrollment 458
Est. completion date March 15, 2022
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - The pathological diagnosis was primary liver cancer. - Undergoing radical surgical treatment - No preoperative antitumor therapy was received - Between 18 and 80 years old Exclusion Criteria: - With distal metastasis - With other tumors - Perioperative death - Recurrence within one month after surgery - Lost contact before the first follow-up

Study Design


Locations

Country Name City State
China Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Data analysis of relationship between CTC and pathological indicators of hepatocellular carcinoma The previous CTC detection data of 458 cases was collected. To compare the relationship between CTC level of perioperative peripheral blood and clinical indexes of HCC patients, the main statistical analysis were one-way ANOVA, Student's T test and Multivariable Cox regression. 2022.03.15
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